MAUDE Adverse Event Report: EXACTECH, INC. EXACTECH; OFFSET CUP IMPACTOR

Catalog Number	121-01-02
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of an fda inspection conducted in jan 2020, exactech, (b)(4) has committed to remediating 3 years of complaints (2017-2020).This mdr is being submitted as part of that remediation.Information was not provided for patient.Visual evaluation condition/findings (conducted with a 7x or l0x optical unless otherwise specified) - the damage to the device appears consistent with using plyers or a similar tool to unscrew the screw from the main assembly of the device.This screw is not intended to be removed and is intended to contain the spring and ball.The looseness of the screw from previous removal may have contributed to the disassembly of the screw spring, the ball.All other aspects of the device appear unremarkable.Design-related issues: the design of the offset cup impactor has been in the field since 2006.Exactech is not aware of any other similar complaint reports involving this device due since 2008.The frequency of occurrence ranking scale is very low; therefore, this issue does not appear to be design related.Mfg-related issues: exactech is not aware of any other complaints involving parts from this manufacturing lot, which has been in the field since 2016.Therefore, this issue does not appear to be manufacturing related.Corrective action is not required because the occurrence rate is " very low", and the risk is captured in the rmr.The disassembly difficulty reported was likely the result of metal binding in the joints of the device, which led to the mechanism being difficult to move.The disassembly of components of the device was likely the result of previous removal or loosening of the screw component, which allowed for it to disassemble ifu 700-096-181: instrument inspection: visually inspect the instruments for damage such as fractures; cracks; gouges; deformation; burrs; discoloration, corrosion, or rust; excessive component wear; nicks on cutting surfaces, missing or loose components; blockages in cannulae, cleaning holes or other cavities that cannot be removed via standard cleaning; worn or difficult to read markings/engravings; or other apparent damage.Check the function of mechanisms by actuating any levers, knobs, switches, connectors, sliding features, hinges, or other mechanical interface features.Ensure smooth operation of these features over their functional range of motion.If damage, wear, or non-functioning/poorly functioning mechanisms are found, do not use the instrument, and contact the sales representative or customer service for disposition.Ifu states: the surgeon shall become thoroughly familiar with the technique of implantation of the prostheses by: appropriate reading of the literature, and training in the operative skills and techniques required for surgery, and reviewing information regarding use of instrumentation.It is a clinical standard of practice in the operating room that all instruments should be visually and functionally inspected before use, these guidelines are from standard association of peri-operative registered nurses (aorn) guidelines.Surgeons are to be familiar and knowledgeable with all instrumentation, devices and proficient with surgical techniques.This device is used for treatment not diagnosis.Based on review of all available information, there is no evidence to reasonably suggest the reported event is related to any manufacturing issues or design issues.The spring and ball ¿fell¿ out of the instrument, all pieces were accounted for.This event did not lead to patient adverse event.An investigation was conducted; the disassembly difficulty reported was likely the result of metal binding in the joints of the device, which led to the mechanism being difficult to move.The disassembly of components of the device was likely the result of previous removal or loosening of the screw component, which allowed for it to disassemble.
Event or Problem Description
It was reported from japan that during an orthopedic surgery the surgeon experienced issues with the offset cup impactor.The cluster holds implant, 48mm, the device was attached and impacted.After impaction, the surgeon could not remove the offset cup impactor in question smoothly from the implant because the release lever ¿was too hard under usual strength¿.¿so, the doctor tried several times and finally he put all his strength into his arm, not like the usual way.He was able to remove it from the implant, but the screw and spring fall off at the same time.The cause and effect are uncertain.All pieces were accounted for and this did not delay surgery.The patient¿s health was stable leaving the operating room.¿ the representative was present at the time of surgery.No patient demographic information was provided.Multiple email requests were sent to the contacts for additional information.No further information has been provided by the contacts related to this event.

• Brand Name: EXACTECH
• Common Device Name: OFFSET CUP IMPACTOR
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th ct.; gainesville FL 32563
• Manufacturer Contact: kate jacobson
• MDR Report Key: 14135864
• Report Number: 1038671-2022-00351
• Device Sequence Number: 19869103
• Product Code: LXH
• UDI-Device Identifier: 10885862020376
• UDI-Public: 10885862020376
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 121-01-02
• Device Lot Number: 79558001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2018
• Initial Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown